CTRI/2019/06/019535
Active, not recruiting
Phase 4
Post-Marketing Phase 4 Study to Evaluate Safety, Tolerability, and Efficacy of Kyprolis (Carfilzomib) in Indian Patients with Relapsed or Refractory Multiple Myeloma: A Prsopective, Open-Label, Non-Comparative, Multicentre Study
Amgen Technology Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: - Health Condition 2: C00-D49- Neoplasms
- Sponsor
- Amgen Technology Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The age limits are being captured as above for the purpose of this CTRI application.
Exclusion Criteria
- •1\. Waldenström macroglobulinemia
- •2\. Plasma cell leukemia
- •3\. POEMS syndrome
- •4\. Myelodysplastic syndrome
- •5\. Primary amyloidosis
- •6\. History of other malignancy within the past 5 years, with the following exception\[s]:
- •Adequately treated non\-melanoma skin cancer or lentigo maligna without evidence of disease.
- •Adequately treated cervical carcinoma in situ without evidence of disease.
- •Adequately treated breast ductal carcinoma in site without evidence of disease.
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 1
Study of B/F/TAF in Participants Switching from CAB + RPV to B/F/TAF for HIV-1 Infection.HIV-1 infectionMedDRA version: 20.1Level: LLTClassification code: 10068341Term: HIV-1 infection Class: 10021881Therapeutic area: Diseases [C] - Virus Diseases [C02]CTIS2023-506660-13-00Gilead Sciences Inc.35
Completed
Phase 4
Post Marketing Study of Eribulin Mesylate in Patients with Breast CancerHealth Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: null- Patients with locally advanced or metastatic breast cancer, who have progressed after at least one regimens of chemotherapy which has included anthracycline and taxane therapyCTRI/2018/03/012349Eisai Pharmaceuticals India Private Limited200
Active, not recruiting
Phase 4
To assess safety and effectiveness of Rivaroxaban(Xarelto)in managing coronary and or symptomatic peripheral artery disease in Indian PatientsHealth Condition 1: I251- Atherosclerotic heart disease of native coronary arteryCTRI/2022/01/039597Bayer Zydus Pharma Pvt Ltd
Active, not recruiting
Phase 1
Safety and tolerability of M254 in healthy volunteers and immune thrombocytopenic purpura (ITP) patientsImmune thrombocytopenic purpuraMedDRA version: 20.1Level: PTClassification code 10074667Term: Immune thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2018-003534-32-HUMomenta Pharmaceuticals, Inc.70
Completed
Phase 2
A 4-part Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 in healthy volunteers and in patients with immune thrombocytopenic purpura.NL-OMON49624Momenta Pharmaceuticals, Inc.30